Cipramil 10mg tablets
*Company:
Lundbeck (Ireland) LimitedStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 13 October 2023
File name
IE_Cipramil_10mg_Tablets_SPC_clean.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 13 October 2023
File name
IE-Cipramil_10mg and 20mg_fct-PIL_clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 13 June 2022
File name
IE Cipramil 10 mg film-coated tablets_SPC clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 13 June 2022
File name
IE Cipramil 10 mg & 20 mg film-coated tablets_PIL clean.pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 2 - interactions with other medicines, food or drink
Updated on 05 May 2021
File name
IE-Cipramil 10mg fct-SPC.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Addition of:
4.4. Special warnings and precautions for use
SSRIs/SNRIs may increase the risk of postpartum haemorrhage (see sections 4.6, 4.8).
4.6. Fertility, pregnancy and lactation
Observational data indicate an increased risk (less than 2-fold) of postpartum haemorrhage following SSRI/SNRI exposure within the month prior to birth (see sections 4.4, 4.8).
4.8. Undesirable effects
Reproductive system and breast disorders: postpartum haemorrhage*; frequency not known
* This event has been reported for the therapeutic class of SSRIs/SNRIs (see sections 4.4, 4.6).
Updated on 05 May 2021
File name
IE-Cipramil 10, 20mg fct-PIL.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
Section 2 warnings and precautions - Addition of:
• History of bleeding disorders […], or if you are pregnant (see ‘Pregnancy’2)
Pregnancy2
If you take Cipramil near the end of your pregnancy there may be an increased risk of heavy vaginal bleeding shortly after birth, especially if you have a history of bleeding disorders. Your doctor or midwife should be aware that you are taking Cipramil so they can advise you.
Section 4 possible side effects - Addition of:
Frequency not known
• Heavy vaginal bleeding shortly after birth (postpartum haemorrhage), see Pregnancy2 in section 2 for more information
Updated on 16 November 2020
File name
REG_013052-1.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 8 - Marketing authorisation number(s)
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 16 November 2020
File name
REG_013057.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 25 May 2020
File name
1-3-1 SPC IE Cipramil 10mg Tablets.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 25 May 2020
File name
1-3-1 IE Cipramil tablets 10mg & 20mg PL.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - how to report a side effect
Updated on 18 October 2019
File name
Cipramil 10 mg film-coated tablets. spc.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Change in section 4.4. Special warnings and precautions for use
Selective serotonin reuptake inhibitors (SSRIs)/serotonin norepinephrine reuptake inhibitors
(SNRIs) may cause symptoms of sexual dysfunction (see section 4.8). There have been reports
of long-lasting sexual dysfunction where the symptoms have continued despite discontinuation
of SSRIs/SNRI.
Updated on 18 October 2019
File name
Cipramil 10 and 20 mg film-coated tablets pl.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Free text change information supplied by the pharmaceutical company
Change in section 2. Warnings and precautions
Medicines like Cipralex (so called SSRIs/SNRIs) may cause symptoms of
sexual dysfunction (see section 4). In some cases, these symptoms have
continued after stopping treatment.
Updated on 11 September 2019
File name
1-3-1 SPC IE Cipramil 10mg Tablets.pdf
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 11 September 2019
File name
1-3-1 IE Cipramil tablets 10mg & 20mg PL_3.pdf
Reasons for updating
- New PIL for new product
Updated on 23 May 2019
File name
1-3-1 SPC IE Cipramil 10mg Tablets.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 06 March 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)